commercially available lansoprazole for Asthma
Phase-Based Progress Estimates
Effectiveness
Safety
Asthma+1 More
commercially available lansoprazole - DrugEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
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Study Summary
This trial will see if lansoprazole works better for children with GER and uncontrolled asthma when the dose is based on their CYP2C19 and ABCB1 genes.
Eligible Conditions
- Asthma
- Gastroesophageal Reflux
Treatment Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
Week 26
Change in Lung Function Testing from Screening through Week 26
Measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
Change in GERD Symptom Assessment Questionnaire Score (GSAS) from Screening through Week 26
Measured at weeks -2 (screening), 0 (baseline), 8, 16, 26
Change in Asthma Control Questionnaire (ACQ) from Screening through Week 26
Change in Asthma Symptom Utility Index (ASUI) from Screening through Week 26
Week 26
Annualized rate of Episodes of Poor Asthma Control (EPAC)
Annualized rate of asthma exacerbations
Annualized rate of respiratory tract infection (RTI)
Trial Safety
Trial Design
2 Treatment Groups
Genotype-guided Lansoprazole
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
110 Total Participants · 2 Treatment Groups
Primary Treatment: commercially available lansoprazole · Has Placebo Group · Phase 3
Genotype-guided Lansoprazole
Drug
Experimental Group · 1 Intervention: commercially available lansoprazole · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: matched placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
Who is running the clinical trial?
Jason Lang, M.D., M.P.H.Lead Sponsor
Nemours Children's ClinicOTHER
110 Previous Clinical Trials
17,827 Total Patients Enrolled
12 Trials studying Asthma
957 Patients Enrolled for Asthma
Thrasher Research FundOTHER
126 Previous Clinical Trials
77,461 Total Patients Enrolled
1 Trials studying Asthma
26 Patients Enrolled for Asthma
Jason E Lang, MD, MPHPrincipal InvestigatorDuke Health
2 Previous Clinical Trials
107 Total Patients Enrolled
Eligibility Criteria
Age < 18 · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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